HHS NEWS
U.S. Department of Health and Human Services
P95-9 Food and Drug Administration
FOR IMMEDIATE RELEASE Judith Foulke (202) 205-4144
Dec. 5, 1995 Home (703) 451-8132
SEAFOOD SAFETY REGULATIONS ANNOUNCED
The Clinton Administration today moved to increase the safety
of the U.S. food supply by requiring that seafood processors use
preventive controls to keep unsafe products from reaching
consumers.
The new Food and Drug Administration regulations represent a
revolution in the way food is protected. The regulations -- based
on principles of a system called Hazard Analysis Critical Control
Point (HACCP) -- replace the approach adopted in the early 1900s
that addressed safety problems after the fact with new procedures
under which food processors will take greater responsibility for
preparing safe food, and government and industry will work more
closely together to protect public health.
It is estimated that these regulations will prevent 20,000 to
60,000 seafood poisonings a year, which cost consumers up to $116
million annually. The regulations lead the way toward a 21st
century food safety system; they will be followed next year by
Department of Agriculture rules for meat and poultry and in
subsequent years by additional FDA regulations covering other
segments of the food supply.
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"Many Americans are making an effort to eat healthier and are
including seafood in their diet," said Health and Human Services
Secretary Donna E. Shalala. "A system that will ensure the safety
of seafood products, regardless of what country or environment they
come from, is a high public health priority. These changes also
represent another step in the Clinton administration's continuing
effort to protect the public health through smart, state-of-the-art
regulations."
The key HACCP components of the system are identification of
potential problems that could make seafood hazardous; establishment
and monitoring of targeted control points to minimize such risks;
and keeping a record of the results.
Under the FDA rule, seafood processors will have to identify
hazards that, without preventive controls, are reasonably likely to
affect the safety of the products. If at least one such hazard can
be identified, the firm will be required to adopt and implement an
appropriate HACCP plan. For example, a highly mechanized
processing line would be checked regularly for metal fragments in
the food and records kept of those checks. In addition to helping
ensure that the food is free of such contaminants, this process
also helps manufacturers who subsequently have problems with their
food determine how and when those problems could have occurred.
Seafood processors using the HACCP system will continue to be
monitored under FDA surveillance and inspection programs. HACCP
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record keeping will enable FDA regulators to monitor product safety
more closely and on a more continuous basis than through spot
checks.
"Our safety inspections should focus on preventing problems
rather than chasing the horses after theyþre out of the barn,þ said
FDA Commissioner David A. Kessler, M.D. þHACCP is a system that
will make that possible."
While the HACCP rules do not apply to fishing vessels or
transporters, processors of imported as well as domestic seafood
must take responsibility for incoming materials. If the supplier
does not provide satisfactory information about the area where the
fish were caught or how they were handled, the HACCP plan will
strengthen the processor's position in refusing to accept the
shipment.
The HACCP regulations contain special provisions to protect
the safety of certain types of products. For instance, processors
of raw molluscan shellfish (oysters, clams and mussels) must
specify in their plans, among other things, that they will accept
only molluscan shellfish that have been harvested from approved
waters. In the case of smoked fish, HACCP controls call for
procedures that will provide safety from Clostridium botulinum
toxin through the shelf life of the product.
Retail seafood operations, while exempt from the FDA rule, are
regulated by state and/or local authorities with training and other
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technical assistance from FDA.
The HACCP regulations for seafood processors will be published
in the Federal Register shortly. The rule will be fully
implemented over the next two years and the agency anticipates
being able to perform HACCP inspections beginning in 1996.
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